Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Edinburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01299194
First received: October 21, 2010
Last updated: January 22, 2014
Last verified: November 2011
  Purpose

Statins are a class of drug used to prevent heart attacks and strokes by lowering blood cholesterol levels. They have also been found to have a beneficial "side effect" of lowering the level of inflammation in the body. This is thought to be one of the reasons they are effective in treating heart attacks and strokes. Laboratory experiments have shown that statins reduce lung inflammation in response to bacteria and this is a promising development for the treatment of chest infections.

Bronchiectasis is a chronic disabling lung disease characterised by chronic sputum production and recurrent chest infections. 2/3 of patients are chronically colonised with bacteria (normally the lungs are sterile) and this leads inflammation in the lung and in the rest of the body.

There are no effective treatments for bronchiectasis other than antibiotics for chest infections. With increasing antibiotic use, there is increasing antibiotic resistance and new treatments for this disease are needed.

The investigators intend to study Atorvastatin in patients with bronchiectasis with colonization with pseudomonas aeruginosa. The investigators will give Atorvastatin to 16 patients with this disease while 16 patients will receive placebo. This will be a crossover study where patients will receive atorvastatin or placebo for 3 months, followed by a statin wash out period of 6 weeks. Thereafter the groups will cross over and the group receiving atorvastatin will now receive placebo and those receiving placebo will receive atorvastatin for 3 months. The investigators will measure inflammation in their lungs and in the rest of their body before and after treatment with atorvastatin. The investigators will also assess their quality of life and number of chest infections over a 7.5 month period.

This pilot study will determine if there is any role for statins are an anti-inflammatory agent in patients with bronchiectasis.


Condition Intervention Phase
BRONCHIECTASIS
Drug: ATORVASTATIN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas Aeruginosa

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • The primary endpoint of this study is a reduction in cough at 3 months compared to baseline as measured by the Leicester Cough Questionnaire score. [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary physiology and assessment of exercise capacity [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
  • 24 hour sputum volume [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
  • qualitative and quantitative bacteriology [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
  • health related quality of life and health care utilisation [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
  • exacerbation frequency [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]
  • safety of statin therapy [ Time Frame: 7.5 months ] [ Designated as safety issue: Yes ]
  • Airways and systemic inflammation [ Time Frame: 7.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ATORVASTATIN
Atorvastatin 80mg once daily for 3 months, 1.5 month wash out, then Placebo for 3 months
Drug: ATORVASTATIN
80mg once daily for 3 months
Placebo Comparator: PLACEBO
Placebo 3 months, then washout for 1.5 months, then Atorvastatin 80mg once daily
Drug: ATORVASTATIN
80mg once daily for 3 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-80 will be recruited.
  • All will have an established radiological diagnosis of bronchiectasis (CT of the chest).
  • Patients colonised with Pseudomonas Aeruginosa.
  • Able to give informed consent.

Exclusion Criteria:

  • Current smokers or ex-smokers of less than 1 year; >15 pack year history
  • Cystic fibrosis
  • Active allergic bronchopulmonary aspergillosis
  • Active tuberculosis
  • Poorly controlled asthma
  • Pregnancy or breast feeding
  • Known allergy to statins
  • Active malignancy
  • Chronic liver disease
  • Established cardiovascular or cerebrovascular disease
  • Statin use in the last year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299194

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Adam T Hill, MBChB MD NHS Lothian
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01299194     History of Changes
Other Study ID Numbers: 2010-022042-24
Study First Received: October 21, 2010
Last Updated: January 22, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
BRONCHIECTASIS
PSEUDOMONAS AERUGINOSA
STATIN
OUTCOME

Additional relevant MeSH terms:
Pseudomonas Infections
Bronchiectasis
Gram-Negative Bacterial Infections
Bacterial Infections
Bronchial Diseases
Respiratory Tract Diseases
Atorvastatin
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014